Duns Number:612250175
Catalog Number
FC0310-45+
Brand Name
AEM® Shield Disposable Electrode, J-Hook
Version/Model Number
FC0310-45+
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
6fb3c021-92b6-4152-a51f-b943011cb50f
Public Version Date
June 27, 2022
Public Version Number
1
DI Record Publish Date
June 17, 2022
Package DI Number
20815288014205
Quantity per Package
10
Contains DI Package
10815288014208
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 208 |